Open, Classified

wDR 2.2 Mobile Digital Diagnostic X-Ray System

FDA Recall Z-2045-2023 · Posted 2023-06-30

Recalling FirmSEDECAL SA

Recall StatusOpen, Classified

Product CodeIZL

Date Initiated2023-05-23

Product Quantity1061 units

Reason for Recall

There is a software login in issue that may prevent the user from logging in.

Firm Action

A recall notification letter was mailed to customers in the United States by the US distributor, Philips, beginning May 23, 2023. Customers are advised to take the following actions: 1) To prevent the system from becoming inoperable, do not reboot or log out of your system until Philips has implemented the software correction. 2) Circulate this notice to all users of the device so that they are aware of the issue. 3) Complete and return the response form to Philips promptly and no later than 30 days from receipt. A Philips representative will contact consignees to schedule a time for a Field Service Engineer to visit the site and implement a software solution to resolve the issue.

Root Cause

Software change control

Distribution Pattern

Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Hungary, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia,Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Zambia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191813MobileDiagnost wDR 2.2Sedecal., Sa. · 2019-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.